Allergan, Gedeon Richter's Vraylar gains expanded US approval in treatment of bipolar depression

Allergan and Gedeon Richter announced Tuesday that the FDA has approved the filing to expand the label for Vraylar (cariprazine) to include use in treating depressive episodes associated with bipolar I disorder in adults. According to the companies, the new indication "makes Vraylar the only dopamine and serotonin partial agonist to treat the full spectrum of bipolar I symptoms in manic, mixed and depressive episodes."

Approval was backed by data from the pivotal RGH-MD-53, RGH-MD-54 and RGH-MD-56 trials. In all three studies, the 1.5-mg dose of Vraylar significantly improved symptoms versus placebo in adults with bipolar I depression, while in RGH-MD-54, the 3-mg dose also demonstrated significance over placebo.

Commenting on the expanded approval, Mizuho analyst Irina Koffler stated "[Allergan] has a long legacy in depression. This is more just building on the strength that they already have." The analyst forecast sales of $683 million for Vraylar this year, with the figure projected to climb to nearly $1.4 billion by 2026 with the label expansion.

Meanwhile, David Nicholson, chief R&D officer at Allergan, noted that the company is also testing Vraylar in autism and as an add-on treatment for major depressive disorder.

Vraylar was previously cleared by the FDA for the acute treatment of manic or mixed episodes associated with bipolar I disorder and schizophrenia in adults, as well as for the maintenance treatment of schizophrenia. In 2017, the agency issued a refuse-to-file letter to Allergan regarding its application seeking approval of the once-daily atypical antipsychotic for treating negative symptoms in schizophrenia.

Sales of Vraylar, which Allergan markets in the US and Canada, jumped 70 percent year-on-year to $143.7 million in the first quarter.   


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